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Study of the Safety and lmmunogenicity of Catch-up Vaccination With a 21-valent Pneumococcal Conjugate Vaccine (PCV21) in Healthy Infants, Toddlers, Children, and Adolescents
EU CTIS ID: 2024-512271-13-00
What this study is testing
To characterize the safety profile of PCV21 after each and any dose Infants (7-11 months of age [MoA]) and toddlers (12-23 MoA): - To describe the serotype specific immunoglobulin type G (IgG) antibody (Ab) level induced by 21-valent pneumococcal conjugate vaccine (PCV21) versus 20-valent pneumococcal conjugate vaccine (20vPCV) for all serotypes included in PCV21 at 30 days after the last dose, as assessed by the geometric mean concentration (GMC) Children (2-5 years of age [YoA]): - To describe the serotype specific opsonophagocytic activity (OPA) titer for all serotypes included in PCV21 at 30 days post-dose - To describe the serotype specific IgG Ab level induced by PCV21 versus 20vPCV for all serotypes included in PCV21 at 30 days post-dose, as assessed by the GMC Children/adolescents (6-17 YoA): - To describe the serotype specific OPA titer for all serotypes included in PCV21 at 30 days post-dose
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Aged 7 months to 17 years on the day of inclusion
- Participants who are healthy as determined by medical evaluation including medical history and physical examination
- For infants (7 to 11 MoA) and toddlers (12 to 23 MoA) only : Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥ 2.5 kg or born after a gestation period above 28 (> 28 weeks) through 36 weeks with a birth weight 1.5 kg, and in both cases medically stable as assessed by the investigator
- For adolescents (6 to 17 YoA) only : A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: ls of non-childbearing potential. To be considered of non-childbearing potential, a female must be pre-menarche or surgically sterile. OR is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to the study vaccine administration until at least 4 weeks after the study vaccine administration. A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 25 hours of before the first dose of study vaccine.
- Assent form has been signed and dated by the participant (based on local regulations), and if applicable, and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative (LAR) and by an independent witness, if required by local regulations
- Participant and parent(s) / LAR(s) are able to attend all scheduled visits and to comply with all study procedures
You likely can't join if
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy
- For children (2 to 5 YoA) and adolescents (6 to 17 YoA) only : previous vaccination with pneumococcal polysaccharide vaccine
- For adolescents (6 to 17 YoA) only : Alcohol, prescription drug, or substance abuse that, in the opinion of the lnvestigator, might interfere with the study conduct or completion
- Receipt of any vaccine in the 4 weeks preceding the vaccine administration or planned receipt of any vaccine in the 4 weeks following the vaccine administration, except for US licensed influenza vaccination, which may be received at least 2 weeks before or 2 weeks after any study vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines, as applicable per local recommendations
- Receipt of immune globulins, blood or blood-derived products in the past 3 months
- For children (2 to 5 YoA) and adolescents (6 to 17 YoA) only : Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
See the full eligibility criteria
Who can join
- Aged 7 months to 17 years on the day of inclusion
- Participants who are healthy as determined by medical evaluation including medical history and physical examination
- For infants (7 to 11 MoA) and toddlers (12 to 23 MoA) only : Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥ 2.5 kg or born after a gestation period above 28 (> 28 weeks) through 36 weeks with a birth weight 1.5 kg, and in both cases medically stable as assessed by the investigator
- For adolescents (6 to 17 YoA) only : A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: ls of non-childbearing potential. To be considered of non-childbearing potential, a female must be pre-menarche or surgically sterile. OR is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to the study vaccine administration until at least 4 weeks after the study vaccine administration. A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 25 hours of before the first dose of study vaccine.
- Assent form has been signed and dated by the participant (based on local regulations), and if applicable, and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative (LAR) and by an independent witness, if required by local regulations
- Participant and parent(s) / LAR(s) are able to attend all scheduled visits and to comply with all study procedures
What rules you out
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy
- For children (2 to 5 YoA) and adolescents (6 to 17 YoA) only : previous vaccination with pneumococcal polysaccharide vaccine
- For adolescents (6 to 17 YoA) only : Alcohol, prescription drug, or substance abuse that, in the opinion of the lnvestigator, might interfere with the study conduct or completion
- Receipt of any vaccine in the 4 weeks preceding the vaccine administration or planned receipt of any vaccine in the 4 weeks following the vaccine administration, except for US licensed influenza vaccination, which may be received at least 2 weeks before or 2 weeks after any study vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines, as applicable per local recommendations
- Receipt of immune globulins, blood or blood-derived products in the past 3 months
- For children (2 to 5 YoA) and adolescents (6 to 17 YoA) only : Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
- Participation at the time of study enrollment (or in the 6 weeks preceding the first vaccine administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
- For adolescents (6 to 17 YoA) only • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily • ldentified as an lnvestigator or employee of the lnvestigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted chiId) of the lnvestigator or employee with direct involvement in the proposed study
- History of microbiologically confirmed S. pneumoniae infection or disease
- History of seizure or significant stable or progressive neurological disorders such as inflammatory nervous system diseases, encephalopathy, and cerebral palsy
- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a product containing any of the same substances
- Laboratory-confirmed thrombocytopenia, or known thrombocytopenia, as reported by the parent(s) / LAR(s), contraindicating intramuscular (IM) injection
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM injection
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
- Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature 38.0°C [100.4°F]) on the day of vaccine administration.
- For infants (7 to 11 MoA) and toddlers (12 to 23 MoA) only : Previous vaccination against S. pneumonia
The study team makes the final eligibility decision.
Where it's taking place
- Thailand
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Thailand; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.